BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4741748 · Received May 1, 2015

    Report

    Report Number
    3004209178-2015-08267
    Event Type
    Malfunction
    Date Received
    May 1, 2015
    Date of Event
    April 2, 2015
    Report Date
    April 10, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TELEMETRY CONFIRMED A CRITICAL ALARM OCCURRED. THE ALARM WAS DUE TO ZERO ML RESERVOIR VOLUME REACHED. PER THE REPORTER THE REFILL DATE WAS MISSED DUE TO SOMEONE AT THE HEALTHCARE PROVIDERS OFFICE WHO WAS NO LONGER THERE. PER THE LOGS THE LOW RESERVOIR ALARM OCCURRED ON (B)(6) 2015 13:04 AND THE EMPTY RESERVOIR ALARM OCCURRED ON (B)(6) 2015 05:17. THEY WERE REFILLING THE PUMP THE DAY OF THE REPORT AND DECREASING THE DOSE TO 150.2MCG/DAY. THERE WAS NO TROUBLESHOOTING OR OTHER ACTIONS TAKEN. THE PATIENT WAS ASYMPTOMATIC BUT HAD FELT A LITTLE TIRED. THE PATIENT HAD NO SYMPTOMS OF UNDERDOSE AND WAS REPORTED AS DOING FINE NOW. THE PATIENT AND MOTHER WERE INSTRUCTED TO CALL THE OFFICE IF ANY UNTOWARD SIDE EFFECTS OCCUR. THE PUMP WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288640 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR